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1. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML

Author

Garcia-Manero, Guillermo, Podoltsev, Nikolai A., Othus, Megan, Pagel, John M., Radich, Jerald P., Fang, Min, Rizzieri, David A., Marcucci, Guido, Strickland, Stephen A., Litzow, Mark R., Savoie, M. Lynn, Medeiros, Bruno C., Sekeres, Mikkael A., Lin, Tara L., Uy, Geoffrey L., Powell, Bayard L., Kolitz, Jonathan E., Larson, Richard A., Stone, Richard M., Claxton, David, Essell, James, Luger, Selina M., Mohan, Sanjay R., Moseley, Anna, Appelbaum, Frederick R., and Erba, Harry P.

Published
2024
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2. Haploidentical vs. sibling, unrelated, or cord blood hematopoietic cell transplantation for acute lymphoblastic leukemia

Author

Wieduwilt, Matthew J, Metheny, Leland, Zhang, Mei-Jie, Wang, Hai-Lin, Estrada-Merly, Noel, Marks, David I, Al-Homsi, A Samar, Muffly, Lori, Chao, Nelson J, Rizzieri, David, Gale, Robert Peter, Gadalla, Shahinaz M, Cairo, Mitchell S, Mussetti, Alberto, Gore, Steven D, Bhatt, Vijaya Raj, Patel, Sagar S, Michelis, Fotios V, Inamoto, Yoshihiro, Badawy, Sherif M, Copelan, Edward, Palmisiano, Neil, Kharfan-Dabaja, Mohamed A, Lazarus, Hillard M, Ganguly, Siddhartha, Bredeson, Christopher N, Perez, Miguel Angel Diaz, Cassaday, Ryan, Savani, Bipin N, Ballen, Karen Kuhn, Martino, Rodrigo, Wirk, Baldeep, Bacher, Ulrike, Aljurf, Mahmoud, Bashey, Asad, Murthy, Hemant S, Yared, Jean A, Aldoss, Ibrahim, Farhadfar, Nosha, Liu, Hongtao, Abdel-Azim, Hisham, Waller, Edmund K, Solh, Melhem, Seftel, Matthew, van der Poel, Marjolein WM, Grunwald, Michael Richard, Liesveld, Jane L, Kamble, Rammurti T, McGuirk, Joseph P, Munker, Reinhold, Cahn, Jean-Yves, Lee, Jong Wook, Freytes, Cesar O, Krem, Maxwell, Winestone, Lena E, Gergis, Usama, Nathan, Sunita, Olsson, Richard F, Verdonck, Leo F, Sharma, Akshay, Ringden, Olle, Friend, Brian D, Cerny, Jan, Choe, Hannah K, Chhabra, Saurabh, Nishihori, Taiga, Seo, Sachiko, George, Biju, Baxter-Lowe, Lee Ann, Hildebrandt, Gerhard C, de Lima, Marcos, Litzow, Mark R, Kebriaei, Partow, Hourigan, Christopher S, Abid, Muhammad Bilal, Weisdorf, Daniel J, and Saber, Wael

Subjects
Rare Diseases, Cancer, Pediatric, Pediatric Cancer, Stem Cell Research - Nonembryonic - Human, Orphan Drug, Hematology, Stem Cell Research, Transplantation, Good Health and Well Being, Fetal Blood, Hematopoietic Stem Cell Transplantation, Humans, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Retrospective Studies, Siblings, Unrelated Donors
Abstract

The role of haploidentical hematopoietic cell transplantation (HCT) using posttransplant cyclophosphamide (PTCy) for acute lymphoblastic leukemia (ALL) is being defined. We performed a retrospective, multivariable analysis comparing outcomes of HCT approaches by donor for adults with ALL in remission. The primary objective was to compare overall survival (OS) among haploidentical HCTs using PTCy and HLA-matched sibling donor (MSD), 8/8 HLA-matched unrelated donor (MUD), 7 /8 HLA-MUD, or umbilical cord blood (UCB) HCT. Comparing haploidentical HCT to MSD HCT, we found that OS, leukemia-free survival (LFS), nonrelapse mortality (NRM), relapse, and acute graft-versus-host disease (aGVHD) were not different but chronic GVHD (cGVHD) was higher in MSD HCT. Compared with MUD HCT, OS, LFS, and relapse were not different, but MUD HCT had increased NRM (hazard ratio [HR], 1.42; P = .02), grade 3 to 4 aGVHD (HR, 1.59; P = .005), and cGVHD. Compared with 7/8 UD HCT, LFS and relapse were not different, but 7/8 UD HCT had worse OS (HR, 1.38; P = .01) and increased NRM (HR, 2.13; P ≤ .001), grade 3 to 4 aGVHD (HR, 1.86; P = .003), and cGVHD (HR, 1.72; P ≤ .001). Compared with UCB HCT, late OS, late LFS, relapse, and cGVHD were not different but UCB HCT had worse early OS (≤18 months; HR, 1.93; P < .001), worse early LFS (HR, 1.40; P = .007) and increased incidences of NRM (HR, 2.08; P < .001) and grade 3 to 4 aGVHD (HR, 1.97; P < .001). Haploidentical HCT using PTCy showed no difference in survival but less GVHD compared with traditional MSD and MUD HCT and is the preferred alternative donor HCT option for adults with ALL in complete remission.

Published
2022

3. Risk classification at diagnosis predicts post-HCT outcomes in intermediate-, adverse-risk, and KMT2A-rearranged AML.

Author

Menghrajani, Kamal, Gomez-Arteaga, Alexandra, Madero-Marroquin, Rafael, Zhang, Mei-Jie, Bo-Subait, Khalid, Sanchez, Jonathan, Wang, Hai-Lin, Aljurf, Mahmoud, Assal, Amer, Bacher, Vera, Badawy, Sherif, Bejanyan, Nelli, Bhatt, Vijaya, Bredeson, Christopher, Byrne, Michael, Castillo, Paul, Cerny, Jan, Chhabra, Saurabh, Ciurea, Stefan, DeFilipp, Zachariah, Farhadfar, Nosha, Gadalla, Shahinaz, Gale, Robert, Ganguly, Siddhartha, Gowda, Lohith, Grunwald, Michael, Hashmi, Shahrukh, Hildebrandt, Gerhard, Kanakry, Christopher, Kansagra, Ankit, Khimani, Farhad, Krem, Maxwell, Lazarus, Hillard, Liu, Hongtao, Martino, Rodrigo, Michelis, Fotios, Nathan, Sunita, Nishihori, Taiga, Olsson, Richard, Reshef, Ran, Rizzieri, David, Rowe, Jacob, Savani, Bipin, Seo, Sachiko, Sharma, Akshay, Solh, Melhem, Ustun, Celalettin, Verdonck, Leo, Hourigan, Christopher, Sandmaier, Brenda, Litzow, Mark, Kebriaei, Partow, Weisdorf, Daniel, Zhang, Yanming, Tallman, Martin, and Saber, Wael

Subjects
Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Recurrence, Remission Induction
Abstract

Little is known about whether risk classification at diagnosis predicts post-hematopoietic cell transplantation (HCT) outcomes in patients with acute myeloid leukemia (AML). We evaluated 8709 patients with AML from the CIBMTR database, and after selection and manual curation of the cytogenetics data, 3779 patients in first complete remission were included in the final analysis: 2384 with intermediate-risk, 969 with adverse-risk, and 426 with KMT2A-rearranged disease. An adjusted multivariable analysis detected an increased risk of relapse for patients with KMT2A-rearranged or adverse-risk AML as compared to those with intermediate-risk disease (hazards ratio [HR], 1.27; P = .01; HR, 1.71; P < .001, respectively). Leukemia-free survival was similar for patients with KMT2A rearrangement or adverse risk (HR, 1.26; P = .002, and HR, 1.47; P < .001), as was overall survival (HR, 1.32; P < .001, and HR, 1.45; P < .001). No differences in outcome were detected when patients were stratified by KMT2A fusion partner. This study is the largest conducted to date on post-HCT outcomes in AML, with manually curated cytogenetics used for risk stratification. Our work demonstrates that risk classification at diagnosis remains predictive of post-HCT outcomes in AML. It also highlights the critical need to develop novel treatment strategies for patients with KMT2A-rearranged and adverse-risk disease.

Published
2022

4. Co-clinical Modeling of the Activity of the BET Inhibitor Mivebresib (ABBV-075) in AML

Author

ALBERT, DANIEL H, GOODWIN, NEAL C, DAVIES, ANGELA M, ROWE, JENNY, FEUER, GEROLD, BOYIADZIS, MICHAEL, DORRITIE, KATHLEEN A, MANCINI, MARIA, GANDOUR-EDWARDS, REGINA, JONAS, BRIAN A, BORTHAKUR, GAUTAM, ALDOSS, IBRAHIM, RIZZIERI, DAVID A, ODENIKE, OLATOYOSI, PREBET, THOMAS, SINGH, SANJANA, POPOVIC, RELJA, SHEN, YU, MCDANIEL, KEITH F, KATI, WARREN M, MODI, DIMPLE A, MOTWANI, MONICA, WOLFF, JOHANNES E, and FROST, DAVID J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Pediatric Cancer, Hematology, Rare Diseases, Pediatric, Pediatric Research Initiative, Orphan Drug, Childhood Leukemia, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Animals, Cell Line, Tumor, Humans, Leukemia, Myeloid, Acute, Mice, Mice, Inbred NOD, Mice, SCID, Pyridones, Sulfonamides, Key Words, Mivebresib, co-clinical PDX models, BRT inhibitors, AML, Oncology & Carcinogenesis, Clinical sciences, Dentistry, Oncology and carcinogenesis
Abstract

Background/aimThe therapeutic potential of bromodomain and extra-terminal motif (BET) inhibitors in hematological cancers has been well established in preclinical and early-stage clinical trials, although as of yet, no BETtargeting agent has achieved approval. To add insight into potential response to mivebresib (ABBV-075), a broadspectrum BET inhibitor, co-clinical modeling of individual patient biopsies was conducted in the context of a Phase I trial in acute myeloid leukemia (AML).Materials and methodsCo-clinical modeling involves taking the patient's biopsy and implanting it in mice with limited passage so that it closely retains the original characteristics of the malignancy and allows comparisons of response between animal model and clinical data. Procedures were developed, initially with neonate NOD/Shi-scid-IL2rγnull (NOG) mice and then optimized with juvenile NOG-EXL as host mice, eventually resulting in a robust rate of engraftment (16 out of 26, 62%).ResultsResults from the co-clinical AML patient-derived xenograft (PDX) modeling (6 with >60% inhibition of bone marrow blasts) were consistent with the equivalent clinical data from patients receiving mivebresib in monotherapy, and in combination with venetoclax. The modeling system also demonstrated the activity of a novel BD2-selective BET inhibitor (ABBV-744) in the preclinical AML setting. Both agents were also highly effective in inhibiting blast counts in the spleen (10/10 and 5/6 models, respectively).ConclusionThese findings confirm the validity of the model system in the co-clinical setting, establish highly relevant in vivo models for the discovery of cancer therapy, and indicate the therapeutic value of BET inhibitors for AML and, potentially, myelofibrosis treatment.

Published
2022

5. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS)

Author

Kantarjian, Hagop M, Begna, Kebede H, Altman, Jessica K, Goldberg, Stuart L, Sekeres, Mikkael A, Strickland, Stephen A, Arellano, Martha L, Claxton, David F, Baer, Maria R, Gautier, Marc, Berman, Ellin, Seiter, Karen, Solomon, Scott R, Schiller, Gary J, Luger, Selina M, Butrym, Aleksandra, Gaidano, Gianluca, Thomas, Xavier G, Montesinos, Pau, Rizzieri, David A, Quick, Donald P, Venugopal, Parameswaran, Gaur, Rakesh, Maness, Lori J, Kadia, Tapan M, Ravandi, Farhad, Buyse, Marc E, and Chiao, Judy H

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Hematology, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Arabinonucleosides, Azacitidine, Cytosine, Decitabine, Humans, Leukemia, Myeloid, Acute, Treatment Outcome, acute myeloid leukemia, decitabine, hypomethylation, sapacitabine, therapy, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundAcute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low-intensity therapy, to elderly patients with newly diagnosed AML.MethodsThis randomized, open-label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1-hour intravenous infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 8 weeks (first cycle and subsequent odd cycles) and sapacitabine 300 mg twice daily on 3 consecutive days per week for 2 weeks every 8 weeks (second cycle and subsequent even cycles) or to control arm C who received 1-hour infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 4 weeks. Prior hypomethylating agent therapy for preexisting myelodysplastic syndromes or myeloproliferative neoplasms was an exclusion criterion. Randomization was stratified by antecedent myelodysplastic syndromes or myeloproliferative neoplasms, white blood cell count (

Published
2021

6. Donor types and outcomes of transplantation in myelofibrosis: a CIBMTR study

Author

Jain, Tania, Estrada-Merly, Noel, Salas, M. Queralt, Kim, Soyoung, DeVos, Jakob, Chen, Min, Fang, Xi, Kumar, Rajat, Andrade-Campos, Marcio, Elmariah, Hany, Agrawal, Vaibhav, Aljurf, Mahmoud, Bacher, Ulrike, Badar, Talha, Badawy, Sherif M., Ballen, Karen, Beitinjaneh, Amer, Bhatt, Vijaya Raj, Bredeson, Christopher, DeFilipp, Zachariah, Dholaria, Bhagirathbhai, Farhadfar, Nosha, Farhan, Shatha, Gandhi, Arpita P., Ganguly, Siddhartha, Gergis, Usama, Grunwald, Michael R., Hamad, Nada, Hamilton, Betty K., Inamoto, Yoshihiro, Iqbal, Madiha, Jamy, Omer, Juckett, Mark, Kharfan-Dabaja, Mohamed A., Krem, Maxwell M., Lad, Deepesh P., Liesveld, Jane, Al Malki, Monzr M., Malone, Adriana K., Murthy, Hemant S., Ortí, Guillermo, Patel, Sagar S., Pawarode, Attaphol, Perales, Miguel-Angel, van der Poel, Marjolein, Ringden, Olle, Rizzieri, David A., Rovó, Alicia, Savani, Bipin N., Savoie, Mary Lynn, Seo, Sachiko, Solh, Melhem, Ustun, Celalettin, Verdonck, Leo F., Wingard, John R., Wirk, Baldeep, Bejanyan, Nelli, Jones, Richard J., Nishihori, Taiga, Oran, Betul, Nakamura, Ryotaro, Scott, Bart, Saber, Wael, and Gupta, Vikas

Published
2024
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7. A phase 1 study of the pan‐bromodomain and extraterminal inhibitor mivebresib (ABBV‐075) alone or in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia

Author

Borthakur, Gautam, Odenike, Olatoyosi, Aldoss, Ibrahim, Rizzieri, David A, Prebet, Thomas, Chen, Chris, Popovic, Relja, Modi, Dimple A, Joshi, Rujuta H, Wolff, Johannes E, and Jonas, Brian A

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Pediatric Cancer, Childhood Leukemia, Rare Diseases, Pediatric, Cancer, Genetics, Clinical Research, Hematology, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Good Health and Well Being, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Humans, Leukemia, Myeloid, Acute, Pyridones, Sulfonamides, ABBV&#8208, 075, acute myeloid leukemia, bromodomain and extraterminal domain protein, mivebresib, phase 1 clinical trial, ABBV-075, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundAcute myeloid leukemia (AML) is a heterogenous malignancy driven by genetic and epigenetic factors. Inhibition of bromodomain and extraterminal (BET) proteins, epigenetic readers that play pivotal roles in the regulation of genes relevant to cancer pathogenesis, constitutes a novel AML treatment approach.MethodsIn this first-in-human study of the pan-BET inhibitor mivebresib as monotherapy (MIV-mono) or in combination with venetoclax (MIV-Ven), the safety profile, efficacy, and pharmacodynamics of mivebresib were determined in patients with relapsed/refractory AML (ClinicalTrials.gov identifier NCT02391480). Mivebresib was administered at 3 monotherapy dose levels (1.5, 2.0, or 2.5 mg) or in combination with venetoclax (400 or 800 mg).ResultsForty-four patients started treatment: of 19 who started MIV-mono, 5 went on to receive MIV-Ven combination therapy after disease progression and a washout period. Twenty-five patients started MIV-Ven, resulting in a total of 30 patients treated with the combination. The most common mivebresib-related treatment-emergent adverse events were dysgeusia (74%), decreased appetite (42%), and diarrhea (42%) in the MIV-mono group and decreased appetite (44%), vomiting (44%), and nausea (40%) in the MIV-Ven group. Serious adverse events occurred in 14 patients (74%) who received MIV-mono and in 22 patients (88%) who received MIV-Ven. In the MIV-mono group, responses were complete remission with incomplete blood count recovery in 1 patient and resistant disease in 15 patients. In the MIV-Ven group, responses were complete remission in 2 patients, partial remission in 2 patients, morphologic leukemia-free state in 2 patients, resistant disease in 12 patients, and aplasia in 1 patient. The pharmacodynamic effects of mivebresib were proportional to dose and drug exposure.ConclusionsMivebresib was tolerated and showed antileukemic effects as monotherapy and in combination with venetoclax in patients with relapsed/refractory AML.Lay summaryMivebresib is a novel drug that influences the way cancer cells read genetic information. Mivebresib was tested together with venetoclax in patients with acute myeloid leukemia after standard medicines failed and the disease returned, or when standard medicine was unavailable. Adverse effects were described for different drug doses, and the dose that is tolerable was determined. In some patients, their leukemia improved for some time. More studies are necessary to determine whether mivebresib can be used to treat acute myeloid leukemia.

Published
2021

8. Impact of cytogenetic abnormalities on outcomes of adult Philadelphia-negative acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation: a study by the Acute Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research

Author

Lazaryan, Aleksandr, Dolan, Michelle, Zhang, Mei-Jie, Wang, Hai-Lin, Kharfan-Dabaja, Mohamed A, Marks, David I, Bejanyan, Nelli, Copelan, Edward, Majhail, Navneet S, Waller, Edmund K, Chao, Nelson, Prestidge, Tim, Nishihori, Taiga, Kebriaei, Partow, Inamoto, Yoshihiro, Hamilton, Betty, Hashmi, Shahrukh K, Kamble, Rammurti T, Bacher, Ulrike, Hildebrandt, Gerhard C, Stiff, Patrick J, McGuirk, Joseph, Aldoss, Ibrahim, Beitinjaneh, Amer M, Muffly, Lori, Vij, Ravi, Olsson, Richard F, Byrne, Michael, Schultz, Kirk R, Aljurf, Mahmoud, Seftel, Matthew, Savoie, Mary Lynn, Savani, Bipin N, Verdonck, Leo F, Cairo, Mitchell S, Hossain, Nasheed, Bhatt, Vijaya Raj, Frangoul, Haydar A, Abdel-Azim, Hisham, Al Malki, Monzr, Munker, Reinhold, Rizzieri, David, Khera, Nandita, Nakamura, Ryotaro, Ringdén, Olle, Van der Poel, Marjolein, Murthy, Hemant S, Liu, Hongtao, Mori, Shahram, De Oliveira, Satiro, Bolaños-Meade, Javier, Elsawy, Mahmoud, Barba, Pere, Nathan, Sunita, George, Biju, Pawarode, Attaphol, Grunwald, Michael, Agrawal, Vaibhav, Wang, Youjin, Assal, Amer, Caro, Paul Castillo, Kuwatsuka, Yachiyo, Seo, Sachiko, Ustun, Celalettin, Politikos, Ioannis, Lazarus, Hillard M, Saber, Wael, Sandmaier, Brenda M, De Lima, Marcos, Litzow, Mark, Bachanova, Veronika, and Weisdorf, Daniel

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cancer, Blood, Adult, Chromosome Aberrations, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

The authors inadvertently included grant numbers OT3HL147741 & U24CA233032, which are grant-specific. This was an oversight on the authors’ part as these grants did not support the research in this publication.

Published
2021

9. Allogeneic hematopoietic cell transplantation for blastic plasmacytoid dendritic cell neoplasm: a CIBMTR analysis

Author

Murthy, Hemant S., Zhang, Mei-Jie, Chen, Karen, Ahmed, Sairah, Deotare, Uday, Ganguly, Siddhartha, Kansagra, Ankit, Michelis, Fotios V., Nishihori, Taiga, Patnaik, Mrinal, Abid, Muhammad Bilal, Aljurf, Mahmoud, Arai, Yasuyuki, Bacher, Ulrike, Badar, Talha, Badawy, Sherif M., Ballen, Karen, Battiwalla, Minoo, Beitinjaneh, Amer, Bejanyan, Nelli, Bhatt, Vijaya Raj, Brown, Valerie I., Martino, Rodrigo, Cahn, Jean-Yves, Castillo, Paul, Cerny, Jan, Chhabra, Saurabh, Copelan, Edward, Daly, Andrew, Dholaria, Bhagirathbhai, Diaz Perez, Miguel Angel, Freytes, César O., Grunwald, Michael R., Hashmi, Shahrukh, Hildebrandt, Gerhard C., Jamy, Omer, Joseph, Jacinth, Kanakry, Christopher G., Khera, Nandita, Krem, Maxwell M., Kuwatsuka, Yachiyo, Lazarus, Hillard M., Lekakis, Lazaros J., Liu, Hongtao, Modi, Dipenkumar, Munshi, Pashna N., Mussetti, Alberto, Palmisiano, Neil, Patel, Sagar S., Rizzieri, David A., Seo, Sachiko, Shah, Mithun Vinod, Sharma, Akshay, Sohl, Melhm, Solomon, Scott R., Ulrickson, Matthew, Ustun, Celalettin, van der Poel, Marjolein, Verdonck, Leo F., Wagner, John L., Wang, Trent, Wirk, Baldeep, Zeidan, Amer, Litzow, Mark, Kebriaei, Partow, Hourigan, Christopher S., Weisdorf, Daniel J., Saber, Wael, and Kharfan-Dabaja, Mohamed A.

Published
2023
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10. Community health status and outcomes after allogeneic hematopoietic cell transplantation in the United States

Author

Hong, Sanghee, Brazauskas, Ruta, Hebert, Kyle M, Ganguly, Siddhartha, Abdel‐Azim, Hisham, Diaz, Miguel Angel, Beattie, Sara, Ciurea, Stefan O, Szwajcer, David, Badawy, Sherif M, Gratwohl, Alois A, LeMaistre, Charles, Aljurf, Mahmoud DSM, Olsson, Richard F, Bhatt, Neel S, Farhadfar, Nosha, Yared, Jean A, Yoshimi, Ayami, Seo, Sachiko, Gergis, Usama, Beitinjaneh, Amer M, Sharma, Akshay, Lazarus, Hillard, Law, Jason, Ulrickson, Matthew, Hashem, Hasan, Schoemans, Hélène, Cerny, Jan, Rizzieri, David, Savani, Bipin N, Kamble, Rammurti T, Shaw, Bronwen E, Khera, Nandita, Wood, William A, Hashmi, Shahrukh, Hahn, Theresa, Lee, Stephanie J, Rizzo, J Douglas, Majhail, Navneet S, and Saber, Wael

Subjects
Hematology, Cancer, Clinical Research, Prevention, Transplantation, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Community Health Planning, Female, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Public Health, Risk Factors, Transplantation, Homologous, Treatment Outcome, United States, Young Adult, allogeneic transplant, community health, hematopoietic cell transplantation, survival, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

BackgroundThe association of community factors and outcomes after hematopoietic cell transplantation (HCT) has not been comprehensively described. Using the County Health Rankings and Roadmaps (CHRR) and the Center for International Blood and Marrow Transplant Research (CIBMTR), this study evaluated the impact of community health status on allogeneic HCT outcomes.MethodsThis study included 18,544 adult allogeneic HCT recipients reported to the CIBMTR by 170 US centers in 2014-2016. Sociodemographic, environmental, and community indicators were derived from the CHRR, an aggregate community risk score was created, and scores were assigned to each patient (patient community risk score [PCS]) and transplant center (center community risk score [CCS]). Higher scores indicated less healthy communities. The impact of PCS and CCS on patient outcomes after allogeneic HCT was studied.ResultsThe median age was 55 years (range, 18-83 years). The median PCS was -0.21 (range, -1.37 to 2.10; standard deviation [SD], 0.42), and the median CCS was -0.13 (range, -1.04 to 0.96; SD, 0.40). In multivariable analyses, a higher PCS was associated with inferior survival (hazard ratio [HR] per 1 SD increase, 1.04; 99% CI, 1.00-1.08; P = .0089). Among hematologic malignancies, a tendency toward inferior survival was observed with a higher PCS (HR, 1.04; 99% CI, 1.00-1.08; P = .0102); a higher PCS was associated with higher nonrelapse mortality (NRM; HR, 1.08; 99% CI, 1.02-1.15; P = .0004). CCS was not significantly associated with survival, relapse, or NRM.ConclusionsPatients residing in counties with a worse community health status have inferior survival as a result of an increased risk of NRM after allogeneic HCT. There was no association between the community health status of the transplant center location and allogeneic HCT outcomes.

Published
2021

11. A simple prognostic system in patients with myelofibrosis undergoing allogeneic stem cell transplantation: a CIBMTR/EBMT analysis

Author

Tamari, Roni, McLornan, Donal P., Ahn, Kwang Woo, Estrada-Merly, Noel, Hernández-Boluda, Juan Carlos, Giralt, Sergio, Palmer, Jeanne, Gale, Robert Peter, DeFilipp, Zachariah, Marks, David I., van der Poel, Marjolein, Verdonck, Leo F., Battiwalla, Minoo, Diaz, Miguel Angel, Gupta, Vikas, Ali, Haris, Litzow, Mark Robert, Lazarus, Hillard M., Gergis, Usama, Bashey, Asad, Liesveld, Jane, Hashmi, Shahrukh, Pu, Jeffrey J., Beitinjaneh, Amer, Bredeson, Christopher, Rizzieri, David, Savani, Bipin N., Abid, Muhammad Bilal, Ganguly, Siddhartha, Agrawal, Vaibhav, Ulrike Bacher, Vera, Wirk, Baldeep, Jain, Tania, Cutler, Corey, Aljurf, Mahmoud, Kindwall-Keller, Tamila, Kharfan-Dabaja, Mohamed A., Hildebrandt, Gerhard C., Pawarode, Attaphol, Solh, Melhem M., Yared, Jean A., Grunwald, Michael R., Nathan, Sunita, Nishihori, Taiga, Seo, Sachiko, Scott, Bart L., Nakamura, Ryotaro, Oran, Betul, Czerw, Tomasz, Yakoub-Agha, Ibrahim, and Saber, Wael

Published
2023
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12. Myeloablative Conditioning for Allogeneic Transplantation Results in Superior Disease-Free Survival for Acute Myelogenous Leukemia and Myelodysplastic Syndromes with Low/Intermediate but not High Disease Risk Index: A Center for International Blood and Marrow Transplant Research Study.

Author

Bejanyan, Nelli, Zhang, Meijie, Bo-Subait, Khalid, Brunstein, Claudio, Wang, Hailin, Warlick, Erica, Giralt, Sergio, Nishihori, Taiga, Martino, Rodrigo, Passweg, Jakob, Dias, Ajoy, Copelan, Edward, Hale, Gregory, Gale, Robert, Solh, Melhem, Kharfan-Dabaja, Mohamed, Diaz, Miguel, Ganguly, Siddhartha, Gore, Steven, Verdonck, Leo, Hossain, Nasheed, Kekre, Natasha, Savani, Bipin, Byrne, Michael, Kanakry, Christopher, Cairo, Mitchell, Ciurea, Stefan, Schouten, Harry, Bredeson, Christopher, Munker, Reinhold, Lazarus, Hillard, Cahn, Jean-Yves, van Der Poel, Marjolein, Rizzieri, David, Yared, Jean, Freytes, Cesar, Cerny, Jan, Aljurf, Mahmoud, Palmisiano, Neil, Pawarode, Attaphol, Bacher, Vera, Grunwald, Michael, Nathan, Sunita, Wirk, Baldeep, Hildebrandt, Gerhard, Seo, Sachiko, Olsson, Richard, George, Biju, de Lima, Marcos, Hourigan, Christopher, Sandmaier, Brenda, Litzow, Mark, Kebriaei, Partow, Saber, Wael, and Weisdorf, Daniel

Subjects
AML, DRI, MDS, Myeloablative, RIC, Adult, Aged, Disease-Free Survival, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Middle Aged, Myelodysplastic Syndromes, Retrospective Studies, Transplantation Conditioning, Transplantation, Homologous
Abstract

Compared with reduced-intensity conditioning (RIC), myeloablative conditioning (MAC) is generally associated with lower relapse risk after allogeneic hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS). However, disease-specific risk factors in AML/MDS can further inform when MAC and RIC may yield differential outcomes. We analyzed HCT outcomes stratified by the Disease Risk Index (DRI) in 4387 adults (age 40 to 65 years) to identify the impact of conditioning intensity. In the low/intermediate-risk DRI cohort, RIC was associated with lower nonrelapse mortality (NRM) (hazard ratio [HR], .74; 95% confidence interval [CI], .62 to .88; P < .001) but significantly greater relapse risk (HR, 1.54; 95% CI, 1.35 to 1.76; P < .001) and thus inferior disease-free survival (DFS) (HR, 1.19; 95% CI, 1.07 to 1.33; P = .001). In the high/very high-risk DRI cohort, RIC was associated with marginally lower NRM (HR, .83; 95% CI, .68 to 1.00; P = .051) and significantly higher relapse risk (HR, 1.23; 95% CI, 1.08 to 1.41; P = .002), leading to similar DFS using either RIC or MAC. These data support MAC over RIC as the preferred conditioning intensity for patients with AML/MDS with low/intermediate-risk DRI, but with a similar benefit as RIC in high/very high-risk DRI. Novel MAC regimens with less toxicity could benefit all patients, but more potent antineoplastic approaches are needed for the high/very-high risk DRI group.

Published
2021

13. Targeting RARA overexpression with tamibarotene, a potent and selective RARα agonist, is a novel approach in AML

Author

de Botton, Stéphane, Cluzeau, Thomas, Vigil, Carlos, Cook, Rachel J., Rousselot, Philippe, Rizzieri, David A., Liesveld, Jane L., Fenaux, Pierre, Braun, Thorsten, Banos, Anne, Jurcic, Joseph G., Sekeres, Mikkael A., Savona, Michael R., Roboz, Gail J., Bixby, Dale, Madigan, Kate, Volkert, Angela, Stephens, Kristin, Kang-Fortner, Qing, Baker, Kristen, Paul, Sofia, McKeown, Michael, Carulli, John, Eaton, Matthew, Hodgson, Graeme, Fiore, Christopher, Kelly, Michael J., Roth, David A., and Stein, Eytan M.

Published
2023
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14. Optimal Donor for African Americans with Hematologic Malignancy: HLA-Haploidentical Relative or Umbilical Cord Blood Transplant

Author

Solomon, Scott R, Martin, Andrew St, Zhang, Mei-Jie, Ballen, Karen, Bashey, Asad, Battiwalla, Minoo, Baxter-Lowe, Lee Ann, Brunstein, Claudio, Chhabra, Saurabh, Perez, Miguel Angel Diaz, Fuchs, Ephraim J, Ganguly, Siddhartha, Hardy, Nancy, Hematti, Peiman, McGuirk, Joseph, Peres, Edward, Ringden, Olle, Rizzieri, David, Romee, Rizwan, Solh, Melhem, Szwajcer, David, van der Poel, Marjolein, Waller, Edmund, William, Basem M, and Eapen, Mary

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Stem Cell Research, Stem Cell Research - Nonembryonic - Human, Clinical Research, Transplantation, Hematology, Stem Cell Research - Umbilical Cord Blood/ Placenta - Human, Rare Diseases, Cancer, Regenerative Medicine, Stem Cell Research - Umbilical Cord Blood/ Placenta, Good Health and Well Being, Black or African American, Cord Blood Stem Cell Transplantation, Fetal Blood, Graft vs Host Disease, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Histocompatibility Testing, Humans, Alternative donor, African American, Caucasian, race, leukemia, transplant-related mortality, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

Although hematopoietic cell transplantation from an HLA-matched unrelated donor is potentially curative for hematologic malignancies, survival is lower for African Americans compared with Caucasians. Because only approximately 20% of African Americans will have an HLA-matched unrelated donor, many of these patients undergo HLA-haploidentical relative or umbilical cord blood transplantation. In this study, we analyzed outcomes after HLA-haploidentical related donor (n = 249) and umbilical cord blood (n = 118) transplantations in African American patients with hematologic malignancy between 2008 and 2016. The predominant disease was acute myelogenous leukemia for recipients of both types of donor grafts. The incidences of grade II-IV and III-IV acute graft-versus-host disease were higher after umbilical cord blood transplantation compared with HLA-haploidentical relative transplantation (56% and 29%, respectively, versus 33% and 11%, respectively; P < .0001). The 2-year incidence of transplantation-related mortality adjusted for age and conditioning regimen intensity was higher after umbilical cord blood transplantation compared with HLA-haploidentical related donor transplantation (31% versus 18%; P = .008); however, there were no between-group differences in the 2-year adjusted incidence of relapse (30% versus 34%; P = .51), overall survival (54% versus 57%; P = .66), or disease-free survival (43% versus 47%; P = .46). Our findings show that the use of HLA-haploidentical and umbilical cord blood transplants expands the access to transplantation with comparable leukemia-free and overall survival for African Americans with hematologic malignancies.

Published
2020

16. Expert consensus on microtransplant for acute myeloid leukemia in elderly patients -report from the international microtransplant interest group

Author

Ai, Huisheng, Chao, Nelson J., Rizzieri, David A., Huang, Xiaojun, Spitzer, Thomas R., Wang, Jianxiang, Guo, Mei, Keating, Armand, Krakow, Elizabeth F., Blaise, Didier, Ma, Jun, Wu, Depei, Reagan, John, Gergis, Usama, Duarte, Rafael F., Chaudhary, Preet M., Hu, Kaixun, Yu, Changlin, Sun, Qiyun, Fuchs, Ephraim, Cai, Bo, Huang, Yajing, Qiao, Jianhui, Gottlieb, David, Schultz, Kirk R., Liu, Mingyao, Chen, Xiequn, Chen, Wenming, Wang, Jianmin, Zhang, Xiaohui, Li, Jianyong, Huang, He, Sun, Zimin, Li, Fei, Yang, Linhua, Zhang, Liansheng, Li, Lijuan, Liu, Kaiyan, Jin, Jie, Liu, Qifa, Liu, Daihong, Gao, Chunji, Fan, Chuanbo, Wei, Li, Zhang, Xi, Hu, Liangding, Zhang, Weijing, Tian, Yuyang, Han, Weidong, Zhu, Jun, Xiao, Zhijian, Zhou, Daobin, Zhang, Bolong, Jia, Yongqian, Zhang, Yongqing, Wu, Xiaoxiong, Shen, Xuliang, Lu, Xuzhang, Zhan, Xinrong, Sun, Xiuli, Xiao, Yi, Wang, Jingbo, Shi, Xiaodong, Zheng, Bo, Chen, Jieping, Ding, Banghe, Wang, Zhao, Zhou, Fan, Zhang, Mei, Zhang, Yizhuo, Sun, Jie, Xia, Bing, Chen, Baoan, and Ma, Liangming

Published
2023
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17. Impact of cytogenetic abnormalities on outcomes of adult Philadelphia-negative acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation: a study by the Acute Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research

Author

Lazaryan, Aleksandr, Dolan, Michelle, Zhang, Mei-Jie, Wang, Hai-Lin, Kharfan-Dabaja, Mohamed A, Marks, David I, Bejanyan, Nelli, Copelan, Edward, Majhail, Navneet S, Waller, Edmund K, Chao, Nelson, Prestidge, Tim, Nishihori, Taiga, Kebriaei, Partow, Inamoto, Yoshihiro, Hamilton, Betty, Hashmi, Shahrukh K, Kamble, Rammurti T, Bacher, Ulrike, Hildebrandt, Gerhard C, Stiff, Patrick J, McGuirk, Joseph, Aldoss, Ibrahim, Beitinjaneh, Amer M, Muffly, Lori, Vij, Ravi, Olsson, Richard F, Byrne, Michael, Schultz, Kirk R, Aljurf, Mahmoud, Seftel, Matthew, Savoie, Mary Lynn, Savani, Bipin N, Verdonck, Leo F, Cairo, Mitchell S, Hossain, Nasheed, Bhatt, Vijaya Raj, Frangoul, Haydar A, Abdel-Azim, Hisham, Malki, Monzr Al, Munker, Reinhold, Rizzieri, David, Khera, Nandita, Nakamura, Ryotaro, Ringdén, Olle, van der Poel, Marjolein, Murthy, Hemant S, Liu, Hongtao, Mori, Shahram, De Oliveira, Satiro, Bolaños-Meade, Javier, Elsawy, Mahmoud, Barba, Pere, Nathan, Sunita, George, Biju, Pawarode, Attaphol, Grunwald, Michael, Agrawal, Vaibhav, Wang, Youjin, Assal, Amer, Caro, Paul Castillo, Kuwatsuka, Yachiyo, Seo, Sachiko, Ustun, Celalettin, Politikos, Ioannis, Lazarus, Hillard M, Saber, Wael, Sandmaier, Brenda M, De Lima, Marcos, Litzow, Mark, Bachanova, Veronika, Weisdorf, Daniel, and Committee of the CIBMTR, Acute Leukemia

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Pediatric Cancer, Transplantation, Childhood Leukemia, Hematology, Cancer, Pediatric, Stem Cell Research, Adult, Chromosome Aberrations, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Retrospective Studies, Transplantation Conditioning, Transplantation, Homologous, Acute Leukemia Committee of the CIBMTR, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Cytogenetic risk stratification at diagnosis has long been one of the most useful tools to assess prognosis in acute lymphoblastic leukemia (ALL). To examine the prognostic impact of cytogenetic abnormalities on outcomes after allogeneic hematopoietic cell transplantation, we studied 1731 adults with Philadelphia-negative ALL in complete remission who underwent myeloablative or reduced intensity/non-myeloablative conditioning transplant from unrelated or matched sibling donors reported to the Center for International Blood and Marrow Transplant Research. A total of 632 patients had abnormal conventional metaphase cytogenetics. The leukemia-free survival and overall survival rates at 5 years after transplantation in patients with abnormal cytogenetics were 40% and 42%, respectively, which were similar to those in patients with a normal karyotype. Of the previously established cytogenetic risk classifications, modified Medical Research Council-Eastern Cooperative Oncology Group score was the only independent prognosticator of leukemia-free survival (P=0.03). In the multivariable analysis, monosomy 7 predicted post-transplant relapse [hazard ratio (HR)=2.11; 95% confidence interval (95% CI): 1.04-4.27] and treatment failure (HR=1.97; 95% CI: 1.20-3.24). Complex karyotype was prognostic for relapse (HR=1.69; 95% CI: 1.06-2.69), whereas t(8;14) predicted treatment failure (HR=2.85; 95% CI: 1.35-6.02) and overall mortality (HR=3.03; 95% CI: 1.44-6.41). This large study suggested a novel transplant-specific cytogenetic scheme with adverse [monosomy 7, complex karyotype, del(7q), t(8;14), t(11;19), del(11q), tetraploidy/near triploidy], intermediate (normal karyotype and all other abnormalities), and favorable (high hyperdiploidy) risks to prognosticate leukemia-free survival (P=0.02). Although some previously established high-risk Philadelphia-negative cytogenetic abnormalities in ALL can be overcome by transplantation, monosomy 7, complex karyotype, and t(8;14) continue to pose significant risks and yield inferior outcomes.

Published
2020

18. An 8-year pragmatic observation evaluation of the benefits of allogeneic HCT in older and medically infirm patients with AML

Author

Sorror, Mohamed L., Gooley, Ted A., Storer, Barry E., Gerds, Aaron T., Sekeres, Mikkael A., Medeiros, Bruno C., Wang, Eunice S., Shami, Paul J., Adekola, Kehinde, Luger, Selina, Baer, Maria R., Rizzieri, David A., Wildes, Tanya M., Koprivnikar, Jamie, Smith, Julie, Garrison, Mitchell, Kojouri, Kiarash, Schuler, Tammy A., Leisenring, Wendy M., Onstad, Lynn E., Becker, Pamela S., McCune, Jeannine S., Lee, Stephanie J., Sandmaier, Brenda M., Appelbaum, Frederick R., and Estey, Elihu H.

Published
2023
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19. P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia

Author

Lin, Kevin H., Rutter, Justine C., Xie, Abigail, Killarney, Shane T., Vaganay, Camille, Benaksas, Chaima, Ling, Frank, Sodaro, Gaetano, Meslin, Paul-Arthur, Bassil, Christopher F., Fenouille, Nina, Hoj, Jacob, Washart, Rachel, Ang, Hazel X., Cerda-Smith, Christian, Chaintreuil, Paul, Jacquel, Arnaud, Auberger, Patrick, Forget, Antoine, Itzykson, Raphael, Lu, Min, Lin, Jiaxing, Pierobon, Mariaelena, Sheng, Zhecheng, Li, Xinghai, Chilkoti, Ashutosh, Owzar, Kouros, Rizzieri, David A., Pardee, Timothy S., Benajiba, Lina, Petricoin, Emanuel, Puissant, Alexandre, and Wood, Kris C.

Published
2022
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21. Outcomes of haploidentical vs matched sibling transplantation for acute myeloid leukemia in first complete remission.

Author

Rashidi, Armin, Hamadani, Mehdi, Zhang, Mei-Jie, Wang, Hai-Lin, Abdel-Azim, Hisham, Aljurf, Mahmoud, Assal, Amer, Bajel, Ashish, Bashey, Asad, Battiwalla, Minoo, Beitinjaneh, Amer, Bejanyan, Nelli, Bhatt, Vijaya, Bolaños-Meade, Javier, Byrne, Michael, Cahn, Jean-Yves, Cairo, Mitchell, Ciurea, Stefan, Copelan, Edward, Cutler, Corey, Daly, Andrew, Diaz, Miguel-Angel, Farhadfar, Nosha, Gale, Robert, Ganguly, Siddhartha, Grunwald, Michael, Hahn, Theresa, Hashmi, Shahrukh, Hildebrandt, Gerhard, Holland, H, Hossain, Nasheed, Kanakry, Christopher, Kharfan-Dabaja, Mohamed, Khera, Nandita, Koc, Yener, Lazarus, Hillard, Lee, Jong-Wook, Maertens, Johan, Martino, Rodrigo, McGuirk, Joseph, Munker, Reinhold, Murthy, Hemant, Nakamura, Ryotaro, Nathan, Sunita, Nishihori, Taiga, Palmisiano, Neil, Patel, Sagar, Pidala, Joseph, Olin, Rebecca, Olsson, Richard, Oran, Betul, Ringden, Olov, Rizzieri, David, Rowe, Jacob, Savoie, Mary, Schultz, Kirk, Seo, Sachiko, Shaffer, Brian, Singh, Anurag, Solh, Melhem, Stockerl-Goldstein, Keith, Verdonck, Leo, Wagner, John, Waller, Edmund, De Lima, Marcos, Sandmaier, Brenda, Litzow, Mark, Weisdorf, Dan, Romee, Rizwan, and Saber, Wael

Subjects
Adolescent, Adult, Aged, Blood Donors, Bone Marrow Transplantation, Calcineurin Inhibitors, Chronic Disease, Cyclophosphamide, Disease-Free Survival, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Incidence, Leukemia, Myeloid, Acute, Male, Middle Aged, Recurrence, Remission Induction, Retrospective Studies, Siblings, Survival Analysis, Transplantation Conditioning, Transplantation, Haploidentical, Young Adult
Abstract

HLA-haploidentical hematopoietic cell transplantation (Haplo-HCT) using posttransplantation cyclophosphamide (PT-Cy) has improved donor availability. However, a matched sibling donor (MSD) is still considered the optimal donor. Using the Center for International Blood and Marrow Transplant Research database, we compared outcomes after Haplo-HCT vs MSD in patients with acute myeloid leukemia (AML) in first complete remission (CR1). Data from 1205 adult CR1 AML patients (2008-2015) were analyzed. A total of 336 patients underwent PT-Cy-based Haplo-HCT and 869 underwent MSD using calcineurin inhibitor-based graft-versus-host disease (GVHD) prophylaxis. The Haplo-HCT group included more reduced-intensity conditioning (65% vs 30%) and bone marrow grafts (62% vs 7%), consistent with current practice. In multivariable analysis, Haplo-HCT and MSD groups were not different with regard to overall survival (P = .15), leukemia-free survival (P = .50), nonrelapse mortality (P = .16), relapse (P = .90), or grade II-IV acute GVHD (P = .98). However, the Haplo-HCT group had a significantly lower rate of chronic GVHD (hazard ratio, 0.38; 95% confidence interval, 0.30-0.48; P < .001). Results of subgroup analyses by conditioning intensity and graft source suggested that the reduced incidence of chronic GVHD in Haplo-HCT is not limited to a specific graft source or conditioning intensity. Center effect and minimal residual disease-donor type interaction were not predictors of outcome. Our results indicate a lower rate of chronic GVHD after PT-Cy-based Haplo-HCT vs MSD using calcineurin inhibitor-based GVHD prophylaxis, but similar other outcomes, in patients with AML in CR1. Haplo-HCT is a viable alternative to MSD in these patients.

Published
2019

23. Impact of depth of clinical response on outcomes of acute myeloid leukemia patients in first complete remission who undergo allogeneic hematopoietic cell transplantation

Author

Percival, Mary-Elizabeth, Wang, Hai-Lin, Zhang, Mei-Jie, Saber, Wael, de Lima, Marcos, Litzow, Mark, Kebriaei, Partow, Abdel-Azim, Hisham, Adekola, Kehinde, Aljurf, Mahmoud, Bacher, Ulrike, Badawy, Sherif M., Beitinjaneh, Amer, Bejanyan, Nelli, Bhatt, Vijaya, Byrne, Michael, Cahn, Jean-Yves, Castillo, Paul, Chao, Nelson, Chhabra, Saurabh, Copelan, Edward, Cutler, Corey, DeFilipp, Zachariah, Dias, Ajoy, Diaz, Miguel Angel, Estey, Elihu, Farhadfar, Nosha, Frangoul, Haydar A., Freytes, César O., Gale, Robert Peter, Ganguly, Siddhartha, Gowda, Lohith, Grunwald, Michael, Hossain, Nasheed, Kamble, Rammurti T., Kanakry, Christopher G., Kansagra, Ankit, Kharfan-Dabaja, Mohamed A., Krem, Maxwell, Lazarus, Hillard M., Lee, Jong Wook, Liesveld, Jane L., Lin, Richard, Liu, Hongtao, McGuirk, Joseph, Munker, Reinhold, Murthy, Hemant S., Nathan, Sunita, Nishihori, Taiga, Olsson, Richard F., Palmisiano, Neil, Passweg, Jakob R., Prestidge, Tim, Ringdén, Olov, Rizzieri, David A., Rybka, Witold B., Savoie, Mary Lynn, Schultz, Kirk R., Seo, Sachiko, Sharma, Akshay, Solh, Melhem, Strair, Roger, van der Poel, Marjolein, Verdonck, Leo F., Yared, Jean A., Weisdorf, Daniel, and Sandmaier, Brenda M.

Published
2021
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24. A phase 2 study of mocetinostat, a histone deacetylase inhibitor, in relapsed or refractory lymphoma

Author

Batlevi, Connie L, Crump, Michael, Andreadis, Charalambos, Rizzieri, David, Assouline, Sarit E, Fox, Susan, Jagt, Richard HC, Copeland, Amanda, Potvin, Diane, Chao, Richard, and Younes, Anas

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Lymphoma, Clinical Research, Orphan Drug, Rare Diseases, Hematology, Cancer, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Benzamides, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Histone Deacetylase Inhibitors, Humans, Kaplan-Meier Estimate, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Pyrimidines, Recurrence, Treatment Outcome, diffuse large B-cell lymphoma, follicular lymphoma, histone deacetylase, mocetinostat, phase 2 study, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Deregulation of histone deacetylase (HDAC) is important in the pathogenesis of follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Mocetinostat, an isotype-selective HDAC inhibitor, induces accumulation of acetylated histones, cell cycle arrest and apoptosis in several cancers. This phase 2 study evaluated mocetinostat in patients with relapsed/refractory (R/R) DLBCL and FL. Seventy-two patients received mocetinostat (starting doses: 70-110 mg TIW, 4-week cycles). The best overall response rate (95% CI) was 18·9% (7·2, 32·2) for the DLBCL cohort (n = 41), and 11·5% (1·7, 20·7) for the FL cohort (n = 31). Responses were durable (≥90 days in 7 of 10 responses). Overall, 54·1% and 73·1% of patients derived clinical benefit (response or stable disease) from mocetinostat in the DLBCL and FL cohorts, respectively. Progression-free survival ranged from 1·8 to 22·8 months and 11·8 to 26·3 months in responders with DLBCL and FL, respectively. The most frequent treatment-related adverse events were fatigue (75·0%), nausea (69·4%) and diarrhoea (61·1%). Although mocetinostat had limited single-agent activity in R/R DLBCL and FL, patients with clinical benefit had long-term disease control. The safety profile was acceptable. This drug class warrants further investigation, including identifying patients more likely to respond to this agent, or in combination with other agents.

Published
2017

25. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML

Author

Garcia-Manero, Guillermo, primary, Podoltsev, Nikolai A., additional, Othus, Megan, additional, Pagel, John M., additional, Radich, Jerald P., additional, Fang, Min, additional, Rizzieri, David A., additional, Marcucci, Guido, additional, Strickland, Stephen A., additional, Litzow, Mark R., additional, Savoie, M. Lynn, additional, Medeiros, Bruno C., additional, Sekeres, Mikkael A., additional, Lin, Tara L., additional, Uy, Geoffrey L., additional, Powell, Bayard L., additional, Kolitz, Jonathan E., additional, Larson, Richard A., additional, Stone, Richard M., additional, Claxton, David, additional, Essell, James, additional, Luger, Selina M., additional, Mohan, Sanjay R., additional, Moseley, Anna, additional, Appelbaum, Frederick R., additional, and Erba, Harry P., additional

Published
2023
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26. Superior survival with pediatric-style chemotherapy compared to myeloablative allogeneic hematopoietic cell transplantation in older adolescents and young adults with Ph-negative acute lymphoblastic leukemia in first complete remission: analysis from CALGB 10403 and the CIBMTR

Author

Wieduwilt, Matthew J., Stock, Wendy, Advani, Anjali, Luger, Selina, Larson, Richard A., Tallman, Martin, Appelbaum, Frederick, Zhang, Mei-Jie, Bo-Subait, Khalid, Wang, Hai-Lin, Bhatt, Vijaya Raj, Dholaria, Bhagirathbhai, Eapen, Mary, Hamadani, Mehdi, Jamy, Omer, Prestidge, Tim, Pulsipher, Michael, Ritchie, David, Rizzieri, David, Sharma, Akshay, Barba, Pere, Sandmaier, Brenda M., de Lima, Marcos, Kebriaei, Partow, Litzow, Mark, Saber, Wael, and Weisdorf, Daniel

Published
2021
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27. Impact of Pretransplantation Renal Dysfunction on Outcomes after Allogeneic Hematopoietic Cell Transplantation

Author

Farhadfar, Nosha, Dias, Ajoy, Wang, Tao, Fretham, Caitrin, Chhabra, Saurabh, Murthy, Hemant S., Broglie, Larisa, D'Souza, Anita, Gadalla, Shahinaz M., Gale, Robert Peter, Hashmi, Shahrukh, Al-Homsi, A. Samer, Hildebrandt, Gerhard C., Hematti, Peiman, Rizzieri, David, Chee, Lynette, Lazarus, Hillard M., Bredeson, Christopher, Jaimes, Edgar A., Beitinjaneh, Amer, Bashey, Asad, Prestidge, Tim, Krem, Maxwell M., Marks, David I., Benoit, Stefanie, Yared, Jean A., Nishihori, Taiga, Olsson, Richard F., Freytes, Cesar O., Stadtmauer, Edward, Savani, Bipin N., Sorror, Mohamed L., Ganguly, Siddhartha, Wingard, John R., and Pasquini, Marcelo

Published
2021
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29. CD98-Mediated Adhesive Signaling Enables the Establishment and Propagation of Acute Myelogenous Leukemia

Author

Bajaj, Jeevisha, Konuma, Takaaki, Lytle, Nikki K, Kwon, Hyog Young, Ablack, Jailal N, Cantor, Joseph M, Rizzieri, David, Chuah, Charles, Oehler, Vivian G, Broome, Elizabeth H, Ball, Edward D, van der Horst, Edward H, Ginsberg, Mark H, and Reya, Tannishtha

Subjects
Biochemistry and Cell Biology, Biomedical and Clinical Sciences, Biological Sciences, Hematology, Pediatric, Childhood Leukemia, Pediatric Cancer, Pediatric Research Initiative, Rare Diseases, Cancer, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Aetiology, 2.1 Biological and endogenous factors, Animals, Antibodies, Cell Adhesion, Cell Line, Tumor, Cell Proliferation, Fusion Regulatory Protein-1, Gene Knockout Techniques, Humans, Leukemia, Myeloid, Acute, Mice, Neoplasm Transplantation, Neoplastic Stem Cells, CD98, SLC3A2, acute myelogenous leukemia, adhesion, cancer, cancer stem cell, imaging, integrin, leukemia, microenvironment, Neurosciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

Acute myelogenous leukemia (AML) is an aggressive disease associated with drug resistance and relapse. To improve therapeutic strategies, it is critical to better understand the mechanisms that underlie AML progression. Here we show that the integrin binding glycoprotein CD98 plays a central role in AML. CD98 promotes AML propagation and lethality by driving engagement of leukemia cells with their microenvironment and maintaining leukemic stem cells. Further, delivery of a humanized anti-CD98 antibody blocks growth of patient-derived AML, highlighting the importance of this pathway in human disease. These findings indicate that microenvironmental interactions are key regulators of AML and that disrupting these signals with targeted inhibitors such as CD98 antibodies may be a valuable therapeutic approach for adults and children with this disease.

Published
2016

30. Clinical and Neuroimaging Correlates of Post-Transplant Delirium

Author

Smith, Patrick, Thompson, Jillian C., Perea, Elena, Wasserman, Brian, Bohannon, Lauren, Racioppi, Alessandro, Choi, Taewoong, Gasparetto, Cristina, Horwitz, Mitchell E., Long, Gwynn, Lopez, Richard, Rizzieri, David A., Sarantopoulos, Stefanie, Sullivan, Keith M., Chao, Nelson J., and Sung, Anthony D.

Published
2020
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31. A Personalized Prediction Model for Outcomes after Allogeneic Hematopoietic Cell Transplant in Patients with Myelodysplastic Syndromes

Author

Nazha, Aziz, Hu, Zhen-Huan, Wang, Tao, Lindsley, R. Coleman, Abdel-Azim, Hisham, Aljurf, Mahmoud, Bacher, Ulrike, Bashey, Asad, Cahn, Jean-Yves, Cerny, Jan, Copelan, Edward, DeFilipp, Zachariah, Diaz, Miguel Angel, Farhadfar, Nosha, Gadalla, Shahinaz M., Gale, Robert Peter, George, Biju, Gergis, Usama, Grunwald, Michael R., Hamilton, Betty, Hashmi, Shahrukh, Hildebrandt, Gerhard C., Inamoto, Yoshihiro, Kalaycio, Matt, Kamble, Rammurti T., Kharfan-Dabaja, Mohamed A., Lazarus, Hillard M., Liesveld, Jane L., Litzow, Mark R., Majhail, Navneet S., Murthy, Hemant S., Nathan, Sunita, Nishihori, Taiga, Pawarode, Attaphol, Rizzieri, David, Sabloff, Mitchell, Savani, Bipin N., Schachter, Levanto, Schouten, Harry C., Seo, Sachiko, Shah, Nirav N., Solh, Melhem, Valcárcel, David, Vij, Ravi, Warlick, Erica, Wirk, Baldeep, Wood, William A., Yared, Jean A., Alyea, Edwin, Popat, Uday, Sobecks, Ronald M., Scott, Bart L., Nakamura, Ryotaro, and Saber, Wael

Published
2020
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32. Comparison of outcomes of HCT in blast phase of BCR-ABL1− MPN with de novo AML and with AML following MDS

Author

Gupta, Vikas, Kim, Soyoung, Hu, Zhen-Huan, Liu, Ying, Aljurf, Mahmoud, Bacher, Ulrike, Beitinjaneh, Amer, Cahn, Jean-Yves, Cerny, Jan, Copelan, Edward, Gadalla, Shahinaz M., Gale, Robert Peter, Ganguly, Siddhartha, George, Biju, Gerds, Aaron T., Gergis, Usama, Hamilton, Betty K., Hashmi, Shahrukh, Hildebrandt, Gerhard C., Kamble, Rammurti T., Kindwall-Keller, Tamila, Lazarus, Hillard M., Liesveld, Jane L., Litzow, Mark, Maziarz, Richard T., Nishihori, Taiga, Olsson, Richard F., Rizzieri, David, Savani, Bipin N., Seo, Sachiko, Solh, Melhem, Szer, Jeff, Verdonck, Leo F., Wirk, Baldeep, Woolfrey, Ann, Yared, Jean A., Alyea, Edwin P., Popat, Uday R., Sobecks, Ronald M., Scott, Bart L., Nakamura, Ryotaro, and Saber, Wael

Published
2020
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33. Optimal Donor for African Americans with Hematologic Malignancy: HLA-Haploidentical Relative or Umbilical Cord Blood Transplant

Author

Solomon, Scott R., Martin, Andrew St, Zhang, Mei-Jie, Ballen, Karen, Bashey, Asad, Battiwalla, Minoo, Baxter-Lowe, Lee Ann, Brunstein, Claudio, Chhabra, Saurabh, Perez, Miguel Angel Diaz, Fuchs, Ephraim J., Ganguly, Siddhartha, Hardy, Nancy, Hematti, Peiman, McGuirk, Joseph, Peres, Edward, Ringden, Olle, Rizzieri, David, Romee, Rizwan, Solh, Melhem, Szwajcer, David, van der Poel, Marjolein, Waller, Edmund, William, Basem M., and Eapen, Mary

Published
2020
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34. The Impact of Donor Type on Outcomes and Cost of Allogeneic Hematopoietic Cell Transplantation for Pediatric Leukemia: A Merged Center for International Blood and Marrow Transplant Research and Pediatric Health Information System Analysis

Author

Arnold, Staci D., Brazauskas, Ruta, He, Naya, Li, Yimei, Hall, Matt, Atsuta, Yoshiko, Dalal, Jignesh, Hahn, Theresa, Khera, Nandita, Bonfim, Carmem, Hashmi, Shahrukh, Parsons, Susan, Wood, William A., Steinberg, Amir, Freytes, César O., Dandoy, Christopher E., Marks, David I., Lazarus, Hillard M., Abdel-Azim, Hisham, Bitan, Menachem, Diaz, Miguel Angel, Olsson, Richard F., Gergis, Usama, Seber, Adriana, Wirk, Baldeep, LeMaistre, C. Fred, Ustun, Celalettin, Duncan, Christine, Rizzieri, David, Szwajcer, David, Fagioli, Franca, Frangoul, Haydar, Knight, Jennifer M., Kamble, Rammurti T., Mehta, Paulette, Schears, Raquel, Satwani, Prakash, Pulsipher, Michael A., Aplenc, Richard, and Saber, Wael

Published
2020
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37. Reduced intensity conditioning for acute myeloid leukemia using melphalan- vs busulfan-based regimens: a CIBMTR report

Author

Zhou, Zheng, Nath, Rajneesh, Cerny, Jan, Wang, Hai-Lin, Zhang, Mei-Jie, Abdel-Azim, Hisham, Agrawal, Vaibhav, Ahmed, Gulrayz, Al-Homsi, A. Samer, Aljurf, Mahmoud, Alkhateeb, Hassan B., Assal, Amer, Bacher, Ulrike, Bajel, Ashish, Bashir, Qaiser, Battiwalla, Minocher, Bhatt, Vijaya Raj, Byrne, Michael, Cahn, Jean-Yves, Cairo, Mitchell, Choe, Hannah, Copelan, Edward, Cutler, Corey, Damlaj, Moussab B., DeFilipp, Zachariah, De Lima, Marcos, Diaz, Miguel Angel, Farhadfar, Nosha, Foran, James, Freytes, César O., Gerds, Aaron T., Gergis, Usama, Grunwald, Michael R., Gul, Zartash, Hamadani, Mehdi, Hashmi, Shahrukh, Hertzberg, Mark, Hildebrandt, Gerhard C., Hossain, Nasheed, Inamoto, Yoshihiro, Isola, Luis, Jain, Tania, Kamble, Rammurti T., Khan, Muhammad Waqas, Kharfan-Dabaja, Mohamed A., Kebriaei, Partow, Kekre, Natasha, Khera, Nandita, Lazarus, Hillard M., Liesveld, Jane L., Litzow, Mark, Liu, Hongtao, Marks, David I., Martino, Rodrigo, Mathews, Vikram, Mishra, Asmita, Murthy, Hemant S., Nagler, Arnon, Nakamura, Ryotaro, Nathan, Sunita, Nishihori, Taiga, Olin, Rebecca, Olsson, Richard F., Palmisiano, Neil, Patel, Sagar S., Patnaik, Mrinal M., Pawarode, Attaphol, Perales, Miguel-Angel, Politikos, Ioannis, Popat, Uday, Rizzieri, David, Sandmaier, Brenda M., Savani, Bipin N., Seo, Sachiko, Shah, Nirav N., Uy, Geoffrey L., Valcárcel, David, Verdonck, Leo F., Waller, Edmund K., Wang, Youjin, Weisdorf, Daniel, Wirk, Baldeep, Wong, Eric, Yared, Jean A., and Saber, Wael

Published
2020
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39. POSTER: AML-303 Tagraxofusp, an Anti-CD123 Therapy, in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm and Prior or Concomitant Hematologic Malignancies: Subgroup Analysis of a Pivotal Trial

Author

Pemmaraju, Naveen, primary, Konopleva, Marina, additional, Sweet, Kendra, additional, Stein, Anthony, additional, Vasu, Sumithira, additional, Rizzieri, David, additional, Wang, Eunice S., additional, Kantarjian, Hagop, additional, Brooks, Christopher, additional, Mughal, Tariq, additional, and Lane, Andrew A., additional

Published
2023
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40. AML-303 Tagraxofusp, an Anti-CD123 Therapy, in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm and Prior or Concomitant Hematologic Malignancies: Subgroup Analysis of a Pivotal Trial

Author

Pemmaraju, Naveen, primary, Konopleva, Marina, additional, Sweet, Kendra, additional, Stein, Anthony, additional, Vasu, Sumithira, additional, Rizzieri, David, additional, Wang, Eunice S., additional, Kantarjian, Hagop, additional, Brooks, Christopher, additional, Mughal, Tariq, additional, and Lane, Andrew A., additional

Published
2023
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41. Use of tamibarotene, a potent and selective RARα agonist, in combination with azacitidine in patients with relapsed and refractory AML with RARA gene overexpression

Author

Stein, Eytan M., primary, de Botton, Stephane, additional, Cluzeau, Thomas, additional, Pigneux, Arnaud, additional, Liesveld, Jane L., additional, Cook, Rachel J., additional, Rousselot, Philippe, additional, Rizzieri, David A., additional, Braun, Thorsten, additional, Roboz, Gail J., additional, Lebon, Delphine, additional, Heiblig, Mael, additional, Baker, Kristen, additional, Volkert, Angela, additional, Paul, Sofia, additional, Rajagopal, Nisha, additional, Roth, David A., additional, Kelly, Michael, additional, and Peterlin, Pierre, additional

Published
2023
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42. PB1773: AML AND MDS WITH RARA OVEREXPRESSION: MOLECULAR AND CLINICAL FEATURES OF PATIENTS ENROLLED IN A PHASE 2 TRIAL EVALUATING TAMIBAROTENE-BASED THERAPY

Author

Botton, Stéphane de, primary, Cluzeau, Thomas, additional, Vigil, Carlos, additional, Cook, Rachel, additional, Rousselot, Philippe, additional, Rizzieri, David, additional, Liesveld, Jane, additional, Fenaux, Pierre, additional, Braun, Thorsten, additional, Pigneux, Arnaud, additional, Peterlin, Pierre, additional, Paul, Sofia, additional, Rajagopal, Nisha, additional, Carulli, John, additional, Roth, David, additional, Volkert, Angela, additional, Malak, Tanya Abdul, additional, Kelly, Michael, additional, Klimek, Virginia, additional, and Stein, Eytan, additional

Published
2023
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43. A Phase I Trial of SYK Inhibition with Fostamatinib in the Prevention and Treatment of Chronic Graft-Versus-Host Disease

Author

Lin, Chenyu, DiCioccio, Rachel A., Haykal, Tarek, McManigle, William C., Li, Zhiguo, Anand, Sarah M., Poe, Jonathan C., Bracken, Sonali J., Jia, Wei, Alyea, Edwin P., III, Cardones, Adela R., Choi, Taewoong, Gasparetto, Cristina, Grunwald, Michael R., Hennig, Therese, Kang, Yubin, Long, Gwynn D., Lopez, Richard, Martin, Melissa, Minor, Kerry K., Quinones, Victor L. Perez, Sung, Anthony D., Wiggins, Kristi, Chao, Nelson J., Horwitz, Mitchell E., Rizzieri, David A., and Sarantopoulos, Stefanie

Published
2023
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44. Tetraspanin 3 Is Required for the Development and Propagation of Acute Myelogenous Leukemia

Author

Kwon, Hyog Young, Bajaj, Jeevisha, Ito, Takahiro, Blevins, Allen, Konuma, Takaaki, Weeks, Joi, Lytle, Nikki K, Koechlein, Claire S, Rizzieri, David, Chuah, Charles, Oehler, Vivian G, Sasik, Roman, Hardiman, Gary, and Reya, Tannishtha

Subjects
Biochemistry and Cell Biology, Biomedical and Clinical Sciences, Biological Sciences, Cancer, Rare Diseases, Childhood Leukemia, Pediatric, Hematology, Stem Cell Research, Pediatric Cancer, Pediatric Research Initiative, 2.1 Biological and endogenous factors, Aetiology, Animals, Carcinogenesis, Cell Movement, Chemokine CXCL12, Genome, Histone-Lysine N-Methyltransferase, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Mice, Inbred C57BL, Mice, Knockout, Myeloid-Lymphoid Leukemia Protein, Neoplastic Stem Cells, Tetraspanins, Xenograft Model Antitumor Assays, Medical and Health Sciences, Developmental Biology, Biological sciences, Biomedical and clinical sciences
Abstract

Acute Myelogenous Leukemia (AML) is an aggressive cancer that strikes both adults and children and is frequently resistant to therapy. Thus, identifying signals needed for AML propagation is a critical step toward developing new approaches for treating this disease. Here, we show that Tetraspanin 3 is a target of the RNA binding protein Musashi 2, which plays a key role in AML. We generated Tspan3 knockout mice that were born without overt defects. However, Tspan3 deletion impaired leukemia stem cell self-renewal and disease propagation and markedly improved survival in mouse models of AML. Additionally, Tspan3 inhibition blocked growth of AML patient samples, suggesting that Tspan3 is also important in human disease. As part of the mechanism, we show that Tspan3 deficiency disabled responses to CXCL12/SDF-1 and led to defects in AML localization within the niche. These identify Tspan3 as an important regulator of aggressive leukemias and highlight a role for Tspan3 in oncogenesis.

Published
2015

49. AML-397 Integrated Safety Analysis of Tagraxofusp, a CD123-Directed Targeted Therapy, in Patients With Hematologic Malignancies

Author

Pammaraju, Naveen, Kantarjian, Hagop, Sweet, Kendra, Wang, Eunice S., Lane, Andrew A., Ali, Haris, Stein, Anthony S., Yacoub, Abdulraheem, Rizzieri, David, Vasu, Sumithira, Gupta, Vikas, Lee, Sangmin, Schiller, Gary J., Foran, James M., Taparia, Minakshi S., Rosenblat, Todd L., Walter, Roland B., Sieminski, Deborah, Anant, Madhu, Patnaik, Mrinal M., Mughal, Tariq I., and Konopleva, Marina

Published
2022
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